ISO 13485 QMS Documentation template wanted

T

tiger2010

#1
I am working on the general quality system preparation in a small start up medical device company . Can anyone help share all of the documentation templates for ISO13485? I know that is a lot!!:eek:
 
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T

tiger2010

#2
Re: Asking for ISO13485 template

Just found this. Very helpful. www clinivation com
Share with you!
 

Ajit Basrur

Staff member
Admin
#4
Re: Asking for ISO13485 template

I am working on the general quality system preparation in a small start up medical device company . Can anyone help share all of the documentation templates for ISO13485? I know that is a lot!!:eek:
Welcome tiger2010. As suggested by my friend harry, there is plenty of information relating to ISO 13485 and you could go through the valuable posts in that section. Do a gap analysis of which specific document / record would you require and come back with specific requirements rather than a general one. Hope you will appreciate it and yes, its a lot :)


Just found this. Very helpful. www clinivation com
Share with you!
Yeah, most of us know about this website. Its a great resource which you have rightly identified. Hope to see more posts from you.
 
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